MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM; DATA MANAGER

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

The siemens regional support center (rsc) evaluated the instrument log files, which indicated that affected samples were omitted over the event weekend.It cannot be determined if they were omitted by a user or by a centralink task.The rsc disabled a filter used in two commands that mark samples for deletion, after which the instrument was operational.The cause of the delay was a configuration issue.Siemens is investigating this issue.

Event Description

Patient sample results, held for validation in centralink, were not validated and uploaded to the customer's laboratory information system (lis), causing delay in reporting.The customer re-sent the results from the analyzer.There are no reports of patient intervention or adverse health consequences due to the delay.

Manufacturer Narrative

Initial mdr 2432235-2017-00650 was filed on 15-dec-2017.Corrected information ( 15-jan-2018): the initial mdr incorrectly noted "siemens is investigating this issue.".Siemens completed the investigation amd determined to be a configuration issue as noted in the initial mdr.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 7122405
• MDR Text Key: 95822478
• Report Number: 2432235-2017-00650
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CENTRALINK DATA MANAGEMENT SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/15/2018
• Supplement Dates FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1